Randomized Study in the Prevention of Pain Shoulders After Laparoscopic Surgery

Not Applicable

Completed

• Conditions: Shoulder Pain

• Registration Number: NCT06039761
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Brief Summary

The purpose of this study is to assess shoulder pain at rest (average over the last 24 hours) assessed by visual analogue scale from 0 to 100mm on Day 1.

Detailed Description

This is an interventional, comparative, controlled, randomized, single-blind study (the patient will be blinded to the result of the randomization, unlike the investigator) and single-center.

Comparative prospective cohort study of laparoscopic surgery with the addition of specific non-surgical interventions aimed at preventing postoperative shoulder pain (use of local intraperitoneal anesthetics, alveolar recruitment maneuver and compression maneuver abdominal) versus without specific interventions aimed at preventing post-operative shoulder pain.

All patients will benefit from Transversus Abdominis Plane block with multimodal analgesia provided in the usual setting of laparoscopic surgery.

Study Timeline

• Study First Submitted: 2023-09-08
• Study First Submitted QC: 2023-09-08
• Study First Posted: 2023-09-15
• Study Start: 2023-12-13
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

• Age ≥ 18 years;
• Celiosurgery including a Transversus Abdominis Plane block with multimodal analgesia;
• Planned laparoscopic surgery for gallbladder, inguinal hernia, umbilical hernia, incisional hernia repair, adnexectomy, oophorectomy, endometriosis, tube ligation;
• Affiliation to the social security scheme;
• Signed informed consent

Exclusion Criteria

• Celiosurgery such as colectomy, bariatric surgery, hysterectomy, prostatectomy, nephrectomy;
• Surgical emergency;
• History of chronic obstructive pulmonary disease;
• Weight less than 50 kg;
• Consumption of preoperative opioids;
• Antidepressant treatment and/or anxiolytic treatment;
• Conversion by laparotomy;
• Intraperitoneal sepsis;
• Major intraoperative complication (hemorrhage, anaphylaxis, etc.);
• Other surgical or medical interventions planned during the study;
• Patient participating in another clinical trial, or during a period of exclusion from another clinical trial;
• Inability to understand information related to the study;
• Woman who is pregnant or likely to be pregnant (of childbearing age, without effective contraception) or currently breastfeeding;
• Patient deprived of liberty or under guardianship or curatorship or unable to give consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Shoulder pain at rest assessed by visual analog scale	1 day	Shoulder pain at rest (average over the last 24 hours) assessed by visual analog scale from 0 to 100mm.; ANCOVA (Analysis of Covariance) analysis will be applied to compare the mean shoulder pain visual analog scal (0 to 100 mm) between the groups, adjusted to the baseline value.

Trial Locations

Locations (1)

Hôpital Privé Dijon Bourgogne; 🇫🇷 Dijon, France